pregabalin

Generic: pregabalin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pregabalin
Generic Name pregabalin
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pregabalin 100 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-500
Product ID 50268-500_40c0f60f-acca-0215-e063-6394a90adfd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209357
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2025-10-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268500
Hyphenated Format 50268-500

Supplemental Identifiers

RxCUI
483438 483440 483442 483448 483450
UNII
55JG375S6M

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pregabalin (source: ndc)
Generic Name pregabalin (source: ndc)
Application Number ANDA209357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX (50268-500-01) / 1 CAPSULE in 1 BLISTER PACK (50268-500-11)
source: ndc

Packages (1)

50268-500-01 100 BLISTER PACK in 1 BOX (50268-500-01) / 1 CAPSULE in 1 BLISTER PACK (50268-500-11)

Ingredients (1)

pregabalin (100 mg/1)

Linked Drug Pages (1)

Pregabalin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40c0f60f-acca-0215-e063-6394a90adfd1", "openfda": {"unii": ["55JG375S6M"], "rxcui": ["483438", "483440", "483442", "483448", "483450"], "spl_set_id": ["40c0f658-2a0a-034b-e063-6394a90a1097"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX (50268-500-01)  / 1 CAPSULE in 1 BLISTER PACK (50268-500-11)", "package_ndc": "50268-500-01", "marketing_start_date": "20251009"}], "brand_name": "Pregabalin", "product_id": "50268-500_40c0f60f-acca-0215-e063-6394a90adfd1", "dosage_form": "CAPSULE", "product_ndc": "50268-500", "dea_schedule": "CV", "generic_name": "Pregabalin", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pregabalin", "active_ingredients": [{"name": "PREGABALIN", "strength": "100 mg/1"}], "application_number": "ANDA209357", "marketing_category": "ANDA", "marketing_start_date": "20251009", "listing_expiration_date": "20261231"}